NDC 69097-852

Naproxen

Naproxen

Naproxen is a Oral Tablet, Delayed Release in the Human Prescription Drug category. It is labeled and distributed by Cipla Usa Inc.. The primary component is Naproxen.

• Product ID: 69097-852_d582dc4b-42a6-45ed-84eb-d701a68592c0
• NDC: 69097-852
• Product Type: Human Prescription Drug
• Proprietary Name: Naproxen
• Generic Name: Naproxen
• Dosage Form: Tablet, Delayed Release
• Route of Administration: ORAL
• Marketing Start Date: 2016-07-05
• Marketing Category: ANDA / ANDA
• Application Number: ANDA091432
• Labeler Name: Cipla USA Inc.
• Substance Name: NAPROXEN
• Active Ingredient Strength: 500 mg/1
• Pharm Classes: Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 69097-852-07

100 TABLET, DELAYED RELEASE in 1 BOTTLE (69097-852-07)

• Marketing Start Date: 2016-07-05
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 69097-852-07 [69097085207]

Naproxen TABLET, DELAYED RELEASE

• Marketing Category: ANDA
• Application Number: ANDA091432
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2016-07-05

NDC 69097-852-12 [69097085212]

Naproxen TABLET, DELAYED RELEASE

• Marketing Category: ANDA
• Application Number: ANDA091432
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2016-07-05

Drug Details

Active Ingredients

Ingredient	Strength
NAPROXEN	500 mg/1

OpenFDA Data

• SPL SET ID: e06c2b43-9882-442e-8413-10d9a33aecb9
• Manufacturer:
  • Cipla USA Inc.
• UNII:
  • 57Y76R9ATQ
• RxNorm Concept Unique ID - RxCUI:
  • 603103
  • 311915
• PHarm Class EPC:
  • Nonsteroidal Anti-inflammatory Drug [EPC]
• UPC Code:
  • 0369097852078
  • 0369097851071
• NUI Code:
  • N0000000160
  • N0000175722
  • N0000175721

Pharmacological Class

• Cyclooxygenase Inhibitors [MoA]
• Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient]
• Nonsteroidal Anti-inflammatory Drug [EPC]

Medicade Reported Pricing

69097085207 NAPROXEN DR 500 MG TABLET

Pricing Unit: EA | Drug Type: